Deep Capsule® (Deep Capsule US)
K-Number: K250655 · 2026-03-12
Decision Date2026-03-12
Product CodeQZF
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Deep Capsule® (Deep Capsule US) is a medical device manufactured by Digestaid - Artificial Intelligence Development SA. It received FDA 510(k) clearance on 2026-03-12 under approval number K250655. The device is classified under product code QZF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Deep Capsule® (Deep Capsule US)?
Deep Capsule® (Deep Capsule US) is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Digestaid - Artificial Intelligence Development SA. The 510(k) number is K250655.
When was Deep Capsule® (Deep Capsule US) approved by the FDA?
Deep Capsule® (Deep Capsule US) received FDA 510(k) clearance on 2026-03-12, under approval number K250655.
What company makes Deep Capsule® (Deep Capsule US)?
Deep Capsule® (Deep Capsule US) is manufactured by Digestaid - Artificial Intelligence Development SA.
What is the FDA product code for Deep Capsule® (Deep Capsule US)?
The FDA product code for Deep Capsule® (Deep Capsule US) is QZF.
Related Devices (Code: QZF)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.